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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED Back to Search Results
Catalog Number 650705550001
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes Pain (1994); Discomfort (2330); Insufficient Information (4580)
Type of Reportable Event Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between (b)(6) 2025.This report summarizes 1 malfunction event(s), where it was reported the device experienced pinch/crush point.There was 1 event with patient involvement; it is unknown at this time what the patient experienced.
 
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.Evaluation results findings (components/results).1 device: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
No new information.
 
Additional Manufacturer Narrative
The device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: controller/dust or dirt problem identified.
 
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Brand Name
6507 POWER PRO 2, HIGH CONFIG
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key24183141
Report Number0001831750-2026-99064
Device Sequence Number15830318
Product Code FPO
UDI-Device Identifier07613327559118
UDI-Public7613327559118
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Exemption NumberVMSR
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/26/2026
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number650705550001
Is the Reporter a Health Professional? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/01/2026
Supplement Date Received by Manufacturer01/01/2026
Initial Report FDA Received Date01/26/2026
Supplement Report FDA Received Date03/26/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Reuse
Patient Sequence Number1
Patient SexUnknown
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